EP1985247A1 - Utilisation d'une fistule - Google Patents

Utilisation d'une fistule Download PDF

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Publication number
EP1985247A1
EP1985247A1 EP08103692A EP08103692A EP1985247A1 EP 1985247 A1 EP1985247 A1 EP 1985247A1 EP 08103692 A EP08103692 A EP 08103692A EP 08103692 A EP08103692 A EP 08103692A EP 1985247 A1 EP1985247 A1 EP 1985247A1
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EP
European Patent Office
Prior art keywords
fistula
insert
tubular body
conformable
filled
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP08103692A
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German (de)
English (en)
Inventor
Ralf Schnell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tracoe Medical GmbH
Original Assignee
Tracoe Medical GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tracoe Medical GmbH filed Critical Tracoe Medical GmbH
Priority to DE202008017361U priority Critical patent/DE202008017361U1/de
Publication of EP1985247A1 publication Critical patent/EP1985247A1/fr
Withdrawn legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/20—Larynxes; Tracheae combined with larynxes or for use therewith
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00641—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closing fistulae, e.g. anorectal fistulae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00659—Type of implements located only on one side of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A61F2002/30583—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with hardenable fluid, e.g. curable in-situ
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0085—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/0468—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters with valves at the proximal end limiting exhalation, e.g. during speaking or coughing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes

Definitions

  • the present invention relates to a fistula insert having a tubular body having a distal and a proximal end and a central lumen, in particular for sealing fistulas in connection with voice prostheses, speaking valves, tracheostomy tubes, stoma buttons and connectors.
  • fistulas or stomata devices such as valves are often used to perform a certain function. Usually, this function is prevented or impaired if the device is not close to the fistula. In the case of valves between the fistula and the valve in particular, there is the possibility that liquids, gases or even solids could pass the valve and thus impair its function.
  • stoma buttons An example of the closure of a stoma are so-called stoma buttons.
  • the task of these buttons is to lie as close as possible to the tracheostoma of a patient.
  • stoma buttons usually have connectivity to aids, such as Speech valves or so-called artificial noses (Heat Moisture Exchanger, short HME). These aids can only work effectively if the stoma button ensures adequate sealing of the stoma. If the seal is inadequate, leaks would prevent the respiratory air from moistening or effectively humidifying.
  • buttons are available in numerous lengths and diameters. Nevertheless, it is not possible to securely seal each stoma with known, commercially available stoma buttons, as the stomata of different patients often vary greatly in size and shape. A fistula or stoma is also unstable and changes over time. Patients with oversized or severely deformed stoma often fix HME or speaking valves with self-adhesive patches with appropriate adapters. The daily change of such patches, however, often leads to skin irritation of the stoma and is also very time consuming and cumbersome.
  • the present invention is therefore based on the object of providing a device for sealing fistulas with voice prostheses, speaking valves, tracheal cannulas or connectors, such as stoma buttons, which, when inserted, are tailored to the size and shape of the stoma or fistula is adaptable and causes a reliable seal.
  • a fistula insert having a tubular body having a distal and a proximal end and a central lumen, the tubular body having an outer surface conformable to the shape of a fistula to be sealed and an inner surface which in the FIG is essentially dimensionally stable, solved.
  • Inner surface is the surface that delimits the central lumen.
  • the conformable outer surface is essentially the surface which contacts the fistula and especially the fistula tract.
  • the longitudinal axis of the central lumen is substantially parallel to the longitudinal extent of the fistula tract.
  • the central lumen of the tubular body may serve for receiving a voice prosthesis, a speaking valve, a tracheostomy tube or a connector.
  • the dimensionally stable inner surface may consist of the outer walls of the inserted voice prosthesis, the speaking valve or the connector.
  • the central lumen may also remain open provided that the insert serves only to keep the fistula open.
  • the lumen of the fistula insert may have a circular cross-section, but are also conceivable oval, elliptical but also angular or irregularly shaped cross-sections.
  • the lumen is not necessarily exactly central in cross section through the tubular body. Particularly in the case of severely deformed fistulas, the lumen can be displaced out of the center, whereby the most central possible position of the inner surface and thus of the lumen is preferred.
  • the proximal end refers to the end that comes to lie in a deployment for a fistula after insertion on the side from which the insert was introduced. In outermost fistula (outer fistula) inserts, therefore, the proximal end is the end protruding out of the body.
  • the distal end refers to the respective opposite end of the tubular body.
  • the distance of the conformable outer surface from the proximal end of the tubular body is at most 10 mm, preferably at most 8 mm, and particularly preferably at most 5 mm.
  • the fistula insert serves to keep fistulas open or to attach or insert any auxiliary means into an outer or inner fistula, and is constructed so that the conformable outer surface will lie in and cover the fistula tract. It is advantageous if the conformable outer surface is as close as possible to the proximal end, so that it protrudes only slightly from the fistula, whereby the risk of irritation or injury to the fistula is reduced by possible uncontrolled movements.
  • both the proximal and the distal end have a small distance to the adaptable outer surface, which is at most 10 mm, preferably at most 8 mm, and particularly preferably at most 5 mm.
  • the conformable outer surface of the tubular body has as close a distance as possible to the distal and proximal ends, so that it comes to lie substantially centrally on the tubular body.
  • the tubular body has a length of 0.4 cm to 6 cm, preferably 0.6 cm to 4 cm. For most artificially created fistulas, this length is sufficient to completely penetrate the fistula tract, so that it is also achieved by the fact that the fistula insert protrudes as slightly as possible from the fistula tract.
  • the length of the conformable outer surface is greater than the length of the fistula tract of the fistula for which the insert is to be used.
  • the conformable outer surface forms a flange at the filling and / or insertion of the insert into the fistula at one or both ends, outside the fistula to be sealed.
  • a flange completely covers the fistula rim at the respective side and fits snugly against the tissue surrounding the fistula. It serves to fix the fistula insert in the fistula.
  • the dimensionally stable inner surface also substantially dimensionally stable flanges.
  • these dimensionally stable flanges may help to prevent the conformable outer surface from expanding towards and closing the central opening during filling.
  • the dimensionally stable flanges must at least as far as they must be passed through the fistula have only such a small radial extent that when inserting the fistula insert, an expansion of the fistula is not or only to a limited extent.
  • a flange may also have a greater extent at an end not to be passed through the fistula, the proximal end.
  • the fistula ends in a tubular duct whose diameter substantially corresponds to that of the fistula and which represents an extension of the fistula, as is the case, for example, in the trachea, which ends after a laryngectomy as an opening in the skin, then according to Embodiment of the insert have at the reaching into this passage end over a smaller flange.
  • This smaller flange can also consist only of the dimensionally stable flange described above, which is independent of the conformable outer surface.
  • the flanges are filled together with or separately from the tubular body and thereby are adaptable to the fistula edges.
  • the outer surface consists of a closed-cell foam.
  • both inner and outer surfaces may consist of a closed cell foam or the entire surface of the tubular body.
  • closed-cell foam surfaces Under closed-cell foam surfaces is a closed-cell foam, which covers only the surface of the fistula insert.
  • the fistula insert can also consist of an integral foam, in which a closed-cell outer skin encloses an open-celled core.
  • a closed-cell outer skin encloses an open-celled core.
  • the outer surface should in any case consist of a deformable soft foam, so that this surface is adaptable to the shape of the fistula.
  • the foam in particular provides a good adaptability of the insert to the shape of a fistula to be sealed.
  • the closed-pore outer surface prevents the penetration of liquid or solids, in particular chyme, in the insert and is at the same time so close to the fistula that even between fistula and use penetration of liquids or solids is not possible.
  • the passage of gas through the insert or between the insert and the fistula can be prevented by such a foam.
  • the foam should be so soft that the pressure exerted on the tissue pressure is less than 30 mbar.
  • At least the outer surface of the fistula insert is comprised of an outer skin defining, together with the inner surface delimiting the central lumen, a volume which can be filled and wherein the outer surface can be adapted to a fistula to be sealed by filling the volume in its shape is.
  • the advantage of this embodiment is that the volume during the filling is adjustable so that the conformable outer surface comes into contact with the fistula tract precisely and on the entire circumference, thereby sealing the fistula.
  • the outer skin may in particular consist of a thin film.
  • This film should in one embodiment consist of a flexible and / or elastic material.
  • the material of the outer surface a material substantially serving to prevent ingress of liquids, solids or gases into the insert and capable of fitting tightly to the fistula can be used.
  • the material with which the insert is filled can essentially have properties which allow a particularly uniform pressure of the insert on the fistula and through which the actual sealing between the fistula and the insert is effected.
  • the pressure on the fistula wall can be adjusted via the filling quantity.
  • the pressure exerted by the insert on the fistula wall should be sufficient to withstand the requirements of the application. It should be weighed between a sufficiently high pressure to ensure the tightness of the fistula insert and in particular to prevent aspiration of the insert by the patient, and a sufficiently low pressure, which prevents damage to the tissue surrounding the fistula.
  • the intact attitude of the tissue is to be preferred in case of doubt.
  • the outer skin may extend only over the adaptable outer surface or over other parts or the entire surface of the insert, provided by the outer skin and other components of the insert, or the speaking valves, voice prostheses or connectors a volume is created, which is filled.
  • the outer skin consists of a thin film which is able to delineate the volume without itself contributing significantly to the volume by its thickness.
  • this film is skin or biocompatible.
  • the film essentially serves to transfer the properties, in particular the pressure, of the filling material to the fistula wall. Moreover, it is able to seal the insert itself well against the environment.
  • the thickness of the film should not be less than 5 microns and not exceed 2 mm and preferably between 75 and 900 microns.
  • the film consists of a flexible and / or elastic material. These materials are particularly well able to conform to the shape of a fistula.
  • the possibility of elastic stretching of the film in an elastic material can be helpful in particular for very large fistulas in the sealing.
  • the use should be filled so that only a moderate pressure is exerted on the fistula, in particular the fistula, the fistula edges and the surrounding tissue, which has no necrosis of the tissue result.
  • the film must adapt to the contour of the fistula and stretch even at low pressures of less than 100 mbar, preferably less than 50 mbar, particularly preferably between 15 and 30 mbar.
  • the resulting slight resistance of the film to stretching allows a more accurate determination of the pressure applied to the fabric surrounding the fistula, as the resistance to stretching of the film counteracts the pressure exerted by the inflation.
  • the fistula insert could, for example, before insertion already be filled. Its outer diameter before insertion is greater than the diameter of the fistula tract. When inserting the fistula insert is compressed in sections and the elastic stretchable film contracts in these areas and is thus wrinkle-free at the fistula.
  • the fistula insert at a filling until the outer skin wrinkle-free but not yet stretched has an outer diameter which is smaller than the diameter of the fistula or this corresponds.
  • Conceivable as a film material would be for certain embodiments, films that are not stretchable or plastically extensible in certain pressure ranges.
  • the films can consist of many different materials or material mixtures.
  • suitable materials are polyurethane, polypropylene, polyethylene, polyethylene terephthalate, polyvinyl chloride or other polymers and mixtures of polymers (blends) as well as SEBS (styrene-ethenebutene-styrene), SBS (styrene-butadiene-styrene), SIS (styrene-isoprene-styrene). Styrene), IR (polyisoprene) or other thermoplastic elastomers, latex, silicone, natural rubber or synthetic rubber.
  • the volume defined by the outer skin can be filled with a fluid or gas. Both liquids and gases distribute the pressure of the insert on the fistula through the outer skin evenly, so that a particularly good seal can be made.
  • the insert could also be filled with a gel that has the same properties.
  • the volume can be filled with a thermosetting liquid.
  • a thermosetting liquid may be, for example, resins or rubbers which polymerize by a chemical reaction within the insert.
  • both single-component and multi-component systems for example made of polyurethane or silicone come into question.
  • materials that have a solidification point at about 42 ° C to 55 ° C so that they have a temperature in the liquid state, which is in principle still bearable for the patient, and does not lead to destruction of the tissue.
  • An example of this would be certain types of paraffin, stearin, beeswax or even polyethylene glycol, eg PEG 1000, PEG 1500, PEG 2000 or PEG 4000 or mixtures thereof. At body temperature solidify these materials or these materials are in their solid state.
  • a crystallization process within the insert would be conceivable.
  • the volume is filled with a supersaturated melt.
  • a targeted solidification of the material takes place due to the onset of the crystallization process.
  • a possible material with such properties for the filling would be, for example, sodium acetate trihydrate.
  • a significant advantage of the use of materials which solidify or crystallize is that the ductility of the material can be restored by re-heating, so that a further adjustment by heating and cooling is possible.
  • the solidified materials are preferably elastically or plastically deformable to a small extent, so that the insert can be removed, for example for cleaning under compression, without greatly stretching the tissue surrounding the fistula.
  • the flexibility should also be so low that the insert is in principle close to the fistula.
  • the insert is filled with a foam.
  • a foam is a soft foam, which is deformable by low pressure. Ingress of liquids or chyme into the foam is prevented in this embodiment by the outer skin.
  • the foam can be formed, for example, by a chemical reaction after filling the insert when it is already in the fistula. In such a soft material, however, it is also conceivable that the foam is already introduced in the production of the insert in the volume defined by the outer skin and sealing occurs during insertion of the insert into the fistula by the slight elastic deformability of the foam. Due to the large number of cells or chambers that make up such a foam that can be compressed independently of one another, such a foam can readily conform to irregularly shaped fistulas.
  • the voice prostheses, speaking valves or connectors are connected to the insert by gluing or welding. These are reasonably stable types of connection which at the same time form a seal between the insert and the respective device contained in the central lumen.
  • the voice prostheses, speaking valves or connectors it would also be conceivable for the voice prostheses, speaking valves or connectors to be screwed into the central lumen with the aid of a thread. It is also expedient if the central lumen is designed as a tube with connector on which voice prostheses or speaking valves can be placed.
  • the outer surface of the insert is provided with a lubricant.
  • a lubricant This facilitates in particular the insertion of the insert into the fistula.
  • a water-soluble lubricant can be used which remains on the outer surface of the insert within the body for only a short time.
  • such a lubricant can also be applied only to the introduction of the insert on the surface.
  • the pressure which the seal exerts on the wall of the fistula is adjustable, so that excessive pressure on the tissue adjacent to the fistula and any necrosis that may occur as a result is prevented.
  • Such adjustability is possible with the substantially foam inserts due to the nature of the foam and the diameter of the insert as compared to the diameter of the fistula for which the insert is to be used, with the pressure on the fistula wall being about 10 should be up to 25 mbar.
  • the outer diameter of the region of the tubular body which comes to rest within the fistula and bears against the fistula tract is particularly preferably filled larger than the diameter of the fistula without external restriction.
  • the insert it is possible to achieve a good seal at the same time very low pressure of the use of the fistula tract and thus the surrounding tissue.
  • the outer surface of the insert can rest in small folds on the fistula, which, however, by the choice of a suitable material of the surface have such a small extent that prevents passage of liquids or gases through the folds becomes.
  • a suitable material of the surface have such a small extent that prevents passage of liquids or gases through the folds becomes.
  • the thickness of the film should be chosen so that it is in the range between 5 .mu.m and 150 .mu.m, preferably between 10 and 70 .mu.m, whereby a sufficient mechanical stability at the same time sufficient Flexibility is guaranteed.
  • the film is substantially non-stretchable, so that the pressure exerted on the tissue surrounding the fistula can be determined directly by measuring the internal pressure during filling.
  • the stability of this embodiment can be improved by filling with a hardening liquid.
  • FIG. 1 a is an inventive fistula insert 1 with a proximal end 2 and a distal end 2 'shown schematically in plan view. It has an outer surface 4, which is adaptable to the shape of the fistula 10 to be sealed.
  • the outer surface 4 which is adaptable to the shape of the fistula 10 to be sealed, formed from a body 4 'made of foam. It is essentially an open-cell foam, which is bounded by a gas and liquid impermeable outer skin, which is the actual adaptable surface forms.
  • the outer skin may be, for example, a closed-cell foam. However, it could also be a thin, flexible, resilient film made of PU, polypropylene, PE, polyethylene terephthalate, PVC, SEBS, SBS, SIS, IR, natural or synthetic rubber, latex, silicone or mixtures thereof or materials having similar properties, which are biocompatible, can exist.
  • the conformable outer surface forming body 4 extends around a substantially dimensionally stable inner surface 5 formed by a likewise tubular body 5'.
  • the tubular body 5 'constituting the inner surface protrudes at both ends 2 and 2' beyond the outer surface 4 forming body 4 '.
  • Flanges 3 and 3 ' are preformed at the two ends 2 and 2', but their outer diameter is not greater than the inner diameter of the fistula 10, which is defined by the fistula edges 12 and the fistula passage 11.
  • the arrow A indicates the direction in which the fistula insert 1 is brought into the fistula 10.
  • FIG. 1b exposes the fistula insert 1 inserted into the fistula 10 FIG. 1a in a fistula.
  • the fistula is shown in longitudinal section. The use is however as in FIG. 1 a to see schematically in a lateral view.
  • the body 4 ' with the outer surface 4 of the fistula insert 1 can be introduced into the fistula 10 without widening of the fistula rim 12 or the fistula passage 11.
  • flanges 6 and 6' are formed on both sides of the fistula.
  • the surface 4 has adapted to the fistula 11, wherein the material of the body 4 'is partially compressed and thereby rests with pressure on the fistula passage 11.
  • the contact pressure of the outer surface 4 on the fistula passage 11 is about 10 to 25 mbar, so that achieves a sufficient seal and at the same time the pressure exerted on the tissue is not so great that it would lead to tissue damage. In such fistula inserts 1 additional control of the pressure is superfluous.
  • the in the FIGS. 1a and 1b correspond to fistula inserts shown, the body 4 'is filled with a material which is able to cure.
  • a material which is able to cure This results in a substantially dimensionally stable body whose surface is no longer readily adaptable after curing.
  • Suitable fillers include, for example, materials which cure reversibly, such as a polyethylene glycol (PEG) which has a solidification temperature of about 40 ° C or a supersaturated melt, or irreversibly harden by a polymerization reaction, wherein the material is chosen so that at least a slight elastic or plastic deformability is still possible.
  • PEG polyethylene glycol
  • Such polymerizing materials are, for example, single- or multi-component silicone rubbers or polyurethane resins.
  • the outer skin of the body 4 ' which forms the outer surface 4 consists of a thin, flexible, elastically extensible film. This film is stretched when inserting the fistula insert sections and therefore lies without wrinkles on the fistula edges and the fistula tract.
  • the curing takes place when the use as in FIG. 1b already shown in the fistula.
  • the filling material is chosen so that the curing takes place with a certain delay, so that any necessary corrections with respect to the seat of the insert 1 in the fistula 10 or the distribution of the material on the flanges 6 and 6 'are still possible.
  • Fistula inserts with reversibly hardening bodies 4 ' can be easily removed from the fistula 10 by reliquefying or restoring the deformability of the material. In irreversibly cured fistula inserts, the removal of the insert is made possible by the slight elastic or plastic deformability.
  • FIG. 2a there is shown a fistula insert 1 having a tubular body with an inner surface 5 and an outer surface 4 conformable to the contour of a fistula 10.
  • the inner surface 5 is thereby formed by a tubular body 5 'having a proximal end 2 and a distal end 2' and a tubular body Body 4 'is partially wrapped, which forms the conformable surface 4.
  • the tubular body 4 ' is located substantially centrally on the circumference of the tubular body 5', is fillable and lies in the FIG. 2a shown unfolded state in folds 8.
  • a valve 9 is provided to fill the body 4 '.
  • a freely deployable state as in FIG.
  • the outer diameter of the body 4 ' would be greater than the inner diameter of the fistula 10.
  • the body 5' has at the ends of flange-like thickenings 3 and 3 ', which serve for stabilization and for the attachment of speaking valves and / or humidity / Heat exchangers are provided.
  • the fistula insert 1 can be introduced into the fistula 10 in the direction of the arrow A.
  • the fistula insert 1 is off FIG. 2a shown as it is shifted into the fistula.
  • the outer diameter of the fistula insert 1, including the outer surface 4 is smaller than the inner diameter of the fistula 10 both in the area of the fistula edges 12 and of the fistula tract 11.
  • the tubular body 4 ' is still in the unfilled state and has an irregular fold 8.
  • the outer skin, the body 4 ', which is the conformable surface 4, consists of a very flexible, soft film, which may also be slightly stretchable. It is biocompatible and gas and liquid impermeable.
  • different gases u. a. Air, or a fluid to be filled.
  • the advantage of such a filling is that for a removal of the fistula insert 1 from the fistula 10 only at least a portion of the gas or the fluid must be removed through the valve 9.
  • a hardening material is filled.
  • the above-described curing materials are suitable.
  • thermosetting material fistula inserts are in contrast to the filled with a gas or a fluid inserts, in which the valve 9 should remain on the body 4 ', also suitable for inner fistulas, since the interfering within the body valve 9 after the Curing the material from the body 4 'can be removed.
  • Figure 2c represents the filled fistula insert 1, the use of the FIGS. 2a and 2b equivalent. Since the length of the body 4 'and thus of the conformable surface 4 is greater than the length of the fistula passage 11, flanges 6 and 6' have been formed at both ends by the filling of the body 4 '.
  • the body 4 when filled without outer boundary has a larger outer diameter than the inner diameter of the fistula 10, for the the fistula insert is to be used, the conformable surface 4 in the inflated state of the body 4 'lies in folds on the fistula tract and the fistula edge. Due to the great flexibility of the film, however, these wrinkles are so small and have such a small diameter at the fold bottom that a seal of the fistula around the fistula insert against gas and liquid is given.
  • the flanges 6 and 6 'forming during filling closely abut the fistula rim and the tissue surrounding the fistula.
  • the distance between these flanges formed by the filling from the thickenings 3 and 3 'present at the ends 2 and 2' in this embodiment is less than 1 cm, often less than 0.5 cm. This minimizes the risk of injury from the overhanging ends of the body 5 'forming the inner surface 5, which is particularly important in inner fistula inserts.
  • Even with outer fistulas, in particular the distance at the proximal end of the insert should not exceed the above values, so that the insert does not protrude unnecessarily far out of the body opening.
  • the body 5 'constituting the inner surface may be incorporated in the embodiments in FIGS FIGS. 1 and 2 consist of a stoma button or a voice prosthesis.
  • the body 4 ' is connected thereto by welding or gluing.
  • a voice prosthesis is attached to the inner surface 5 by welding or gluing within the tubular body 5 '.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Anesthesiology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Medical Informatics (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Prostheses (AREA)
EP08103692A 2007-04-27 2008-04-23 Utilisation d'une fistule Withdrawn EP1985247A1 (fr)

Priority Applications (1)

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DE202008017361U DE202008017361U1 (de) 2007-04-27 2008-04-23 Fisteleinsatz

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DE102007021111A DE102007021111A1 (de) 2007-04-27 2007-04-27 Fisteleinsatz

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EP1985247A1 true EP1985247A1 (fr) 2008-10-29

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US (1) US20080275402A1 (fr)
EP (1) EP1985247A1 (fr)
DE (2) DE102007021111A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2265185A4 (fr) * 2008-04-04 2011-05-04 Curaseal Inc Dispositif implantable d'obturation de fistule
US9131941B2 (en) 2011-06-17 2015-09-15 Curaseal Inc. Fistula treatment devices and methods
US9211116B2 (en) 2011-06-16 2015-12-15 Curaseal Inc. Fistula treatment devices and related methods
US9993235B2 (en) 2008-09-04 2018-06-12 Curaseal Inc. Enteric fistula treatment devices
WO2022219388A1 (fr) * 2021-04-15 2022-10-20 Manopen Irodatechnikai Korlátolt Felelősségű Társaság Néosphincter

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GB2443164B (en) * 2006-10-24 2011-03-30 Univ Hull Speech valve
EP2854921A1 (fr) * 2012-06-01 2015-04-08 Koninklijke Philips N.V. Dispositif d'interface respiratoire pour administrer un gaz à l'utilisateur
US9044195B2 (en) 2013-05-02 2015-06-02 University Of South Florida Implantable sonic windows
GB201411628D0 (en) * 2014-06-30 2014-08-13 Abseal Aps Device
US10028733B2 (en) 2015-05-28 2018-07-24 National University Of Ireland, Galway Fistula treatment device
US11701096B2 (en) 2015-05-28 2023-07-18 National University Of Ireland, Galway Fistula treatment device
EP3518841B2 (fr) * 2016-10-03 2024-10-16 Hollister Incorporated Barriere de stomie avec convexite ajustable
EP3541298B1 (fr) 2017-06-09 2021-08-18 Signum Surgical Limited Implant pour fermer une ouverture dans un tissu
US11666696B2 (en) * 2019-03-25 2023-06-06 Ellen McGrath Enterostomy drainage methods and devices
EP4157412A4 (fr) * 2020-06-02 2024-05-22 Coloplast A/S Support de dispositif de trachéostomie

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WO1992010981A1 (fr) * 1990-12-21 1992-07-09 Brigham And Women's Hospital Tube vocal
WO1999000073A1 (fr) * 1997-06-28 1999-01-07 Anson Medical Limited Dispositif gonflable
JP2003235879A (ja) * 2002-02-19 2003-08-26 Meiji Univ 動物用フィステル
DE102005015045A1 (de) * 2005-03-31 2006-10-05 Tracoe Medical Gmbh Beschichtete Manschette
WO2006133927A2 (fr) * 2005-06-17 2006-12-21 Microcuff Gmbh Dispositif d'alimentation et de drainage gastrique a travers une stomie artificielle

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US4459984A (en) * 1982-09-15 1984-07-17 Liegner Kenneth B Speaking tracheostomy tube
US7087041B2 (en) * 1998-02-25 2006-08-08 Zassi Medical Evolutions, Inc. Pad for use with continent ostomy port
SE512029C2 (sv) * 1998-05-14 2000-01-17 Atos Medical Ab Talventil med filter
CA2561193A1 (fr) * 2004-03-26 2005-10-20 Satiety, Inc. Systemes et methodes de traitement de l'obesite
JP4539974B2 (ja) * 2004-10-05 2010-09-08 日本シャーウッド株式会社 気管切開チューブ
WO2006084456A1 (fr) * 2005-02-10 2006-08-17 Weinmann Geräte für Medizin GmbH & Co. KG Dispositif de ventilation et procede de commande d'un respirateur

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Publication number Priority date Publication date Assignee Title
WO1992010981A1 (fr) * 1990-12-21 1992-07-09 Brigham And Women's Hospital Tube vocal
WO1999000073A1 (fr) * 1997-06-28 1999-01-07 Anson Medical Limited Dispositif gonflable
JP2003235879A (ja) * 2002-02-19 2003-08-26 Meiji Univ 動物用フィステル
DE102005015045A1 (de) * 2005-03-31 2006-10-05 Tracoe Medical Gmbh Beschichtete Manschette
WO2006133927A2 (fr) * 2005-06-17 2006-12-21 Microcuff Gmbh Dispositif d'alimentation et de drainage gastrique a travers une stomie artificielle

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2265185A4 (fr) * 2008-04-04 2011-05-04 Curaseal Inc Dispositif implantable d'obturation de fistule
US9993235B2 (en) 2008-09-04 2018-06-12 Curaseal Inc. Enteric fistula treatment devices
US9211116B2 (en) 2011-06-16 2015-12-15 Curaseal Inc. Fistula treatment devices and related methods
US9131941B2 (en) 2011-06-17 2015-09-15 Curaseal Inc. Fistula treatment devices and methods
WO2022219388A1 (fr) * 2021-04-15 2022-10-20 Manopen Irodatechnikai Korlátolt Felelősségű Társaság Néosphincter

Also Published As

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US20080275402A1 (en) 2008-11-06
DE102007021111A1 (de) 2008-10-30
DE202008017361U1 (de) 2009-07-30

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